AtherosclerosisICONICNCT02959099
Incident COronary EveNts Identified by Computed Tomography
An observational study of Atherosclerosis, run by Weill Medical College of Cornell University at 13 sites in 8 countries.
Trial summary
The Incident COronary EveNts Identified by Coronary Tomography (ICONIC) trial is a nested, case-control study derived from the dynamic CONFIRM registry, and is based on propensity scoring methods to match subjects with (cases) or without (controls) acute coronary syndrome (ACS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerosis
- How many people
- 476 participants
- Where
- 13 sitesin 8 countries
- Study dates
- 20 Jul 2012to 30 Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects were recruited from 13 international sites in Asia, Europe and North America, with central adjudication of clinical outcomes and core-laboratory measurement of CCTA-based plaque characteristics. Subjects recruited in ICONIC represent individuals suspected of having CAD, meeting the inclusion criteria, and undergoing coronary luminal evaluation using ≥ 64-detector row CCTA. Subjects with established CAD were excluded from the trial. The two arms of the study were patients with baseline CCTA and subsequent occurrence of an ACS event (cases) and patients with baseline CCTA and no subsequent ACS event (controls).
Who may be able to join
- Age ≥18 years.
- Adjudicated STEMI / NSTEMI / UA / Unclassified MI (except for type 4a, 4b, or 5 MI)
- Baseline CCTA.
- Age ≥18 years.
- Propensity score matched.
Who cannot join
- Myocardial infarction not meeting the definition of ACS with missing cardiac biomarkers.
- Prior history of CAD (revascularization or MI).
- Prior revascularization (PCI or CABG).
- ACS in a previously revascularized segment.
- Type 4a, 4b, or 5 MI.
- Controls
- Prior history of CAD (revascularization or MI).
- Death as an outcome.
Trial locations and contacts
13 sites in 8 countries.
13 sites in 8 countries
United States3 sites
Walter Reed Army Medical Center
Bethesda, Maryland, 20889
Baptist Hospital of Miami
Miami, Florida, 33176
William Beaumont Hospital
Royal Oak, Michigan, 48073
Canada2 sites
University of Ottawa Heart Institute
Ottawa, Ontario
Providence Health Care St. Paul's Hospital
Vancouver
Italy2 sites
Department of Clinical Sciences and Community Health, University of Milan & Centro Cardiologico Monzino, IRCCS
Milan
University Hospital of Parma
Parma
South Korea2 sites
Seoul National University Hospital
Seoul
Severance Cardiovascular Hospital
Seoul
About this study
The Incident COronary EveNts Identified by Coronary Tomography (ICONIC) trial is a nested, case-control study derived from the dynamic CONFIRM registry, and is based on propensity scoring methods to match subjects with (cases) or without (controls) acute coronary syndrome (ACS). Our primary objective is to determine CCTA-based atherosclerotic plaque characteristics that would help elucidate precursors of incident ACS, with the secondary objective being an analysis of gender-specific disparities.
Read the detailed description
Acute myocardial infarctions resulting from unstable plaque in patients with coronary artery disease (CAD) account for a significant portion of cardiovascular morbidity and mortality. Although prediction models that incorporate traditional risk factors have been developed in order to risk stratify patients at highest risk for development of subsequent cardiovascular events, such models lack precision and are often found to over or under-estimate risk. Moreover, current clinical practice has focused on stenosis severity as a predictor of future plaque erosion and/or rupture, in spite of the fact that evidence from intravascular ultrasound (IVUS) studies, such as the PROSPECT trial, demonstrate that ACS events are more likely to occur in less than severely stenotic lesions. Furthermore, there is incomplete understanding of the influence of gender on atherosclerotic plaque composition and downstream coronary events, given the chronologic and prognostic differences between men and women in atherosclerotic cardiovascular disease.
Several studies have attempted elucidating characteristics of vulnerable plaque using invasive imaging modalities such as IVUS. However, such studies have several limitations, most significantly is the fact that plaque characterization was performed after an acute coronary event, which limits the ability to isolate baseline plaque characteristics from changes following the acute event. Noninvasive evaluation of atherosclerotic coronary disease using coronary computed tomographic angiography (CCTA) has been established as an accurate and readily available imaging modality in clinical practice. In addition to the evaluation of diameter stenosis, CCTA is capable of evaluation plaque composition as well as arterial remodeling, in a similar fashion to IVUS. The agreement between plaque characterization using IVUS and CCTA has been demonstrated in several large-scale trials. Nevertheless, there are several key aspects that have yet to be addressed, including the utility of plaque characterization by CCTA for determination of future cardiovascular events, and gender-based differences in atherosclerotic plaque composition in patients with stable and unstable coronary artery disease.
The ICONIC trial was designed as a nested case-control study based on the previously published CONFIRM registry, evaluating demographic, clinical as well as baseline CCTA-determined plaque composition in 238 patients with subsequent ACS events and 238 matched patients without ACS events. As previously described, ICONIC utilizes CCTA to comprehensively assess plaque morphology and characteristics, in addition to arterial wall changes in order to determine characteristics implicated in future adverse events, beyond what has been traditionally described using invasive imaging modalities. The primary goal is to investigate differences in atherosclerotic plaque composition in patients with ACS, compared to patients with stable coronary disease. The secondary goal is to determine gender-specific differences in plaque composition in both stable and unstable coronary artery disease.
- Conditions
- Atherosclerosis
- Keywords
- Acute coronary syndrome (ACS), Atherosclerotic plaque morphology, Coronary Computed Tomographic Angiography (CCTA), Gender disparities
- Medical subject headings
- Atherosclerosis, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Patients with acute coronary syndrome (ACS). | |
| Controls | Patients without acute coronary syndrome (ACS). |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACS
ACS: ST elevation MI (STEMI), non-ST elevation MI (NSTEMI), or unstable angina (UA)
Measured: within 5 years
Secondary outcomes (1)
STEMI and NSTEMI
ST elevation MI (STEMI) or Non-ST elevation MI (NSTEMI)
Measured: within 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study start20 Jul 2012
- Primary completion30 Apr 2017
- Study completion30 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 476 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leslee J Shaw, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02959099
- Sponsor's protocol ID
- 1310014469
- Acronym
- ICONIC
- Status last verified
- Nov 2019
- First submitted
- 4 Nov 2016
- Last updated
- 19 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Min JK, Dunning A, Lin FY, Achenbach S, Al-Mallah MH, Berman DS, Budoff MJ, Cademartiri F, Callister TQ, Chang HJ, Cheng V, Chinnaiyan KM, Chow B, Delago A, Hadamitzky M, Hausleiter J, Karlsberg RP, Kaufmann P, Maffei E, Nasir K, Pencina MJ, Raff GL, Shaw LJ, Villines TC. Rationale and design of the CONFIRM (COronary CT Angiography EvaluatioN For Clinical Outcomes: An InteRnational Multicenter) Registry. J Cardiovasc Comput Tomogr. 2011 Mar-Apr;5(2):84-92. doi: 10.1016/j.jcct.2011.01.007. Epub 2011 Feb 1.
PubMed 21477786Motoyama S, Kondo T, Sarai M, Sugiura A, Harigaya H, Sato T, Inoue K, Okumura M, Ishii J, Anno H, Virmani R, Ozaki Y, Hishida H, Narula J. Multislice computed tomographic characteristics of coronary lesions in acute coronary syndromes. J Am Coll Cardiol. 2007 Jul 24;50(4):319-26. doi: 10.1016/j.jacc.2007.03.044. Epub 2007 Jul 6.
PubMed 17659199Motoyama S, Sarai M, Harigaya H, Anno H, Inoue K, Hara T, Naruse H, Ishii J, Hishida H, Wong ND, Virmani R, Kondo T, Ozaki Y, Narula J. Computed tomographic angiography characteristics of atherosclerotic plaques subsequently resulting in acute coronary syndrome. J Am Coll Cardiol. 2009 Jun 30;54(1):49-57. doi: 10.1016/j.jacc.2009.02.068.
PubMed 19555840Pflederer T, Marwan M, Schepis T, Ropers D, Seltmann M, Muschiol G, Daniel WG, Achenbach S. Characterization of culprit lesions in acute coronary syndromes using coronary dual-source CT angiography. Atherosclerosis. 2010 Aug;211(2):437-44. doi: 10.1016/j.atherosclerosis.2010.02.001. Epub 2010 Feb 10.
PubMed 20189568Cheng VY, Nakazato R, Dey D, Gurudevan S, Tabak J, Budoff MJ, Karlsberg RP, Min J, Berman DS. Reproducibility of coronary artery plaque volume and composition quantification by 64-detector row coronary computed tomographic angiography: an intraobserver, interobserver, and interscan variability study. J Cardiovasc Comput Tomogr. 2009 Sep-Oct;3(5):312-20. doi: 10.1016/j.jcct.2009.07.001. Epub 2009 Jul 30.
PubMed 19709947Pundziute G, Schuijf JD, van Velzen JE, Jukema JW, van Werkhoven JM, Nucifora G, van der Kley F, Kroft LJ, de Roos A, Boersma E, Reiber JH, Schalij MJ, van der Wall EE, Bax JJ. Assessment with multi-slice computed tomography and gray-scale and virtual histology intravascular ultrasound of gender-specific differences in extent and composition of coronary atherosclerotic plaques in relation to age. Am J Cardiol. 2010 Feb 15;105(4):480-6. doi: 10.1016/j.amjcard.2009.09.054. Epub 2010 Jan 5.
PubMed 20152242Malkasian S, Nurmohamed NS, Chang HJ, Choi AD, Marques H, Molloi S, van Rosendael A, Chow BJW, Andreini D, Conte E, Maffei E, Plank F, Pontone G, Feuchtner G, Samady H, Park HB, Danad I, Cho I, Bax JJ, Lee HJ, Sung JM, Baskaran L, Hadamitzky M, Budoff MJ, Stone PH, Heo R, Cury RC, Lee SE, Al'Aref SJ, Stuijfzand WJ, Kim YJ, Cademartiri F, Virmani R, Narula J, Chinnaiyan K, Villines TC, Leipsic J, Shaw LJ, Lin FY, Crabtree T, Hoffman U, Earls JP. Association of Low-Attenuation Noncalcified Plaque Shape and Degree of Intraplaque Embeddedness Using Atherosclerotic Imaging-enabled Quantitative CT with Acute Coronary Syndrome. Radiol Cardiothorac Imaging. 2026 Aug;8(4):e250117. doi: 10.1148/ryct.250117.
PubMed 42489557Kwan AC, Tzolos E, Klein E, Han D, Lin A, Kuronuma K, Chen B, Flores Tomasino G, Gransar H, Slomka PJ, Cheng S, Gebhard C, Kaufmann P, Bax JJ, Cademartiri F, Chinnaiyan K, Chow BJW, Conte E, Cury RC, Feuchtner G, Hadamitzky M, Kim YJ, Leipsic JA, Maffei E, Marques H, Plank F, Pontone G, Villines TC, Al-Mallah MH, Goncalves PA, Danad I, Lu Y, Lee JH, Lee SE, Baskaran L, Al'Aref SJ, Budoff MJ, Samady H, Stone PH, Virmani R, Achenbach S, Narula J, Chang HJ, Shaw LJ, Berman DS, Lin F, Dey D. Pericoronary Adipose Tissue Attenuation in Patients with Future Acute Coronary Syndromes: The ICONIC Study. Radiol Cardiothorac Imaging. 2025 Jun;7(3):e240200. doi: 10.1148/ryct.240200.
PubMed 40539913
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incident COronary EveNts Identified by Computed Tomography
- ClinicalTrials.gov ID
- NCT02959099
- Acronym / sponsor ID
- ICONIC / 1310014469
- Conditions
- Atherosclerosis
- Keywords
- Acute coronary syndrome (ACS), Atherosclerotic plaque morphology, Coronary Computed Tomographic Angiography (CCTA), Gender disparities
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 476 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 20 Jul 2012 (actual)
- Primary completion
- 30 Apr 2017 (actual)
- Study completion
- 30 Apr 2017 (actual)
- First posted
- 8 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Incident COronary EveNts Identified by Coronary Tomography (ICONIC) trial is a nested, case-control study derived from the dynamic CONFIRM registry, and is based on propensity scoring methods to match subjects with (cases) or without (controls) acute coronary syndrome (ACS). Our primary objective is to determine CCTA-based atherosclerotic plaque characteristics that would help elucidate precursors of incident ACS, with the secondary objective being an analysis of gender-specific disparities.
Detailed description
Acute myocardial infarctions resulting from unstable plaque in patients with coronary artery disease (CAD) account for a significant portion of cardiovascular morbidity and mortality. Although prediction models that incorporate traditional risk factors have been developed in order to risk stratify patients at highest risk for development of subsequent cardiovascular events, such models lack precision and are often found to over or under-estimate risk. Moreover, current clinical practice has focused on stenosis severity as a predictor of future plaque erosion and/or rupture, in spite of the fact that evidence from intravascular ultrasound (IVUS) studies, such as the PROSPECT trial, demonstrate that ACS events are more likely to occur in less than severely stenotic lesions. Furthermore, there is incomplete understanding of the influence of gender on atherosclerotic plaque composition and downstream coronary events, given the chronologic and prognostic differences between men and women in atherosclerotic cardiovascular disease.
Several studies have attempted elucidating characteristics of vulnerable plaque using invasive imaging modalities such as IVUS. However, such studies have several limitations, most significantly is the fact that plaque characterization was performed after an acute coronary event, which limits the ability to isolate baseline plaque characteristics from changes following the acute event. Noninvasive evaluation of atherosclerotic coronary disease using coronary computed tomographic angiography (CCTA) has been established as an accurate and readily available imaging modality in clinical practice. In addition to the evaluation of diameter stenosis, CCTA is capable of evaluation plaque composition as well as arterial remodeling, in a similar fashion to IVUS. The agreement between plaque characterization using IVUS and CCTA has been demonstrated in several large-scale trials. Nevertheless, there are several key aspects that have yet to be addressed, including the utility of plaque characterization by CCTA for determination of future cardiovascular events, and gender-based differences in atherosclerotic plaque composition in patients with stable and unstable coronary artery disease.
The ICONIC trial was designed as a nested case-control study based on the previously published CONFIRM registry, evaluating demographic, clinical as well as baseline CCTA-determined plaque composition in 238 patients with subsequent ACS events and 238 matched patients without ACS events. As previously described, ICONIC utilizes CCTA to comprehensively assess plaque morphology and characteristics, in addition to arterial wall changes in order to determine characteristics implicated in future adverse events, beyond what has been traditionally described using invasive imaging modalities. The primary goal is to investigate differences in atherosclerotic plaque composition in patients with ACS, compared to patients with stable coronary disease. The secondary goal is to determine gender-specific differences in plaque composition in both stable and unstable coronary artery disease.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | –Patients with acute coronary syndrome (ACS). |
| Controls | – | –Patients without acute coronary syndrome (ACS). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects were recruited from 13 international sites in Asia, Europe and North America, with central adjudication of clinical outcomes and core-laboratory measurement of CCTA-based plaque characteristics. Subjects recruited in ICONIC represent individuals suspected of having CAD, meeting the inclusion criteria, and undergoing coronary luminal evaluation using ≥ 64-detector row CCTA. Subjects with established CAD were excluded from the trial. The two arms of the study were patients with baseline CCTA and subsequent occurrence of an ACS event (cases) and patients with baseline CCTA and no subsequent ACS event (controls).
Key inclusion criteria (5 listed)
- Age ≥18 years.
- Adjudicated STEMI / NSTEMI / UA / Unclassified MI (except for type 4a, 4b, or 5 MI)
- Baseline CCTA.
- Age ≥18 years.
- Propensity score matched.
Key exclusion criteria (8 listed)
- Myocardial infarction not meeting the definition of ACS with missing cardiac biomarkers.
- Prior history of CAD (revascularization or MI).
- Prior revascularization (PCI or CABG).
- ACS in a previously revascularized segment.
- Type 4a, 4b, or 5 MI.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ACS
Time frame: within 5 years
ACS: ST elevation MI (STEMI), non-ST elevation MI (NSTEMI), or unstable angina (UA)
1 secondary outcome
STEMI and NSTEMI
Time frame: within 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
- Background: PubMed 21477786Min JK, Dunning A, Lin FY, Achenbach S, Al-Mallah MH, Berman DS, Budoff MJ, Cademartiri F, Callister TQ, Chang HJ, Cheng V, Chinnaiyan KM, Chow B, Delago A, Hadamitzky M, Hausleiter J, Karlsberg RP, Kaufmann P, Maffei E, Nasir K, Pencina MJ, Raff GL, Shaw LJ, Villines TC. Rationale and design of the CONFIRM (COronary CT Angiography EvaluatioN For Clinical Outcomes: An InteRnational Multicenter) Registry. J Cardiovasc Comput Tomogr. 2011 Mar-Apr;5(2):84-92. doi: 10.1016/j.jcct.2011.01.007. Epub 2011 Feb 1.
- Background: PubMed 17659199Motoyama S, Kondo T, Sarai M, Sugiura A, Harigaya H, Sato T, Inoue K, Okumura M, Ishii J, Anno H, Virmani R, Ozaki Y, Hishida H, Narula J. Multislice computed tomographic characteristics of coronary lesions in acute coronary syndromes. J Am Coll Cardiol. 2007 Jul 24;50(4):319-26. doi: 10.1016/j.jacc.2007.03.044. Epub 2007 Jul 6.
- Background: PubMed 19555840Motoyama S, Sarai M, Harigaya H, Anno H, Inoue K, Hara T, Naruse H, Ishii J, Hishida H, Wong ND, Virmani R, Kondo T, Ozaki Y, Narula J. Computed tomographic angiography characteristics of atherosclerotic plaques subsequently resulting in acute coronary syndrome. J Am Coll Cardiol. 2009 Jun 30;54(1):49-57. doi: 10.1016/j.jacc.2009.02.068.
- Background: PubMed 20189568Pflederer T, Marwan M, Schepis T, Ropers D, Seltmann M, Muschiol G, Daniel WG, Achenbach S. Characterization of culprit lesions in acute coronary syndromes using coronary dual-source CT angiography. Atherosclerosis. 2010 Aug;211(2):437-44. doi: 10.1016/j.atherosclerosis.2010.02.001. Epub 2010 Feb 10.
- Background: PubMed 19709947Cheng VY, Nakazato R, Dey D, Gurudevan S, Tabak J, Budoff MJ, Karlsberg RP, Min J, Berman DS. Reproducibility of coronary artery plaque volume and composition quantification by 64-detector row coronary computed tomographic angiography: an intraobserver, interobserver, and interscan variability study. J Cardiovasc Comput Tomogr. 2009 Sep-Oct;3(5):312-20. doi: 10.1016/j.jcct.2009.07.001. Epub 2009 Jul 30.
- Background: PubMed 20152242Pundziute G, Schuijf JD, van Velzen JE, Jukema JW, van Werkhoven JM, Nucifora G, van der Kley F, Kroft LJ, de Roos A, Boersma E, Reiber JH, Schalij MJ, van der Wall EE, Bax JJ. Assessment with multi-slice computed tomography and gray-scale and virtual histology intravascular ultrasound of gender-specific differences in extent and composition of coronary atherosclerotic plaques in relation to age. Am J Cardiol. 2010 Feb 15;105(4):480-6. doi: 10.1016/j.amjcard.2009.09.054. Epub 2010 Jan 5.
- Derived from this study: PubMed 42489557Malkasian S, Nurmohamed NS, Chang HJ, Choi AD, Marques H, Molloi S, van Rosendael A, Chow BJW, Andreini D, Conte E, Maffei E, Plank F, Pontone G, Feuchtner G, Samady H, Park HB, Danad I, Cho I, Bax JJ, Lee HJ, Sung JM, Baskaran L, Hadamitzky M, Budoff MJ, Stone PH, Heo R, Cury RC, Lee SE, Al'Aref SJ, Stuijfzand WJ, Kim YJ, Cademartiri F, Virmani R, Narula J, Chinnaiyan K, Villines TC, Leipsic J, Shaw LJ, Lin FY, Crabtree T, Hoffman U, Earls JP. Association of Low-Attenuation Noncalcified Plaque Shape and Degree of Intraplaque Embeddedness Using Atherosclerotic Imaging-enabled Quantitative CT with Acute Coronary Syndrome. Radiol Cardiothorac Imaging. 2026 Aug;8(4):e250117. doi: 10.1148/ryct.250117.
- Derived from this study: PubMed 40539913Kwan AC, Tzolos E, Klein E, Han D, Lin A, Kuronuma K, Chen B, Flores Tomasino G, Gransar H, Slomka PJ, Cheng S, Gebhard C, Kaufmann P, Bax JJ, Cademartiri F, Chinnaiyan K, Chow BJW, Conte E, Cury RC, Feuchtner G, Hadamitzky M, Kim YJ, Leipsic JA, Maffei E, Marques H, Plank F, Pontone G, Villines TC, Al-Mallah MH, Goncalves PA, Danad I, Lu Y, Lee JH, Lee SE, Baskaran L, Al'Aref SJ, Budoff MJ, Samady H, Stone PH, Virmani R, Achenbach S, Narula J, Chang HJ, Shaw LJ, Berman DS, Lin F, Dey D. Pericoronary Adipose Tissue Attenuation in Patients with Future Acute Coronary Syndromes: The ICONIC Study. Radiol Cardiothorac Imaging. 2025 Jun;7(3):e240200. doi: 10.1148/ryct.240200.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leslee J Shaw, PhD principal investigator
Weill Medical College of Cornell University
13 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis, run by Weill Medical College of Cornell University at 13 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Canada, Italy, South Korea, Austria and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ACS (time frame: within 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02959099, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2019.